A conceptual model for the development process of confirmatory adaptive clinical trials within an emergency research network.

ABSTRACT:

Background

Adaptive clinical trials use accumulating data from enrolled subjects to alter trial conduct in pre-specified ways based on quantitative decision rules. In this research, we sought to characterize the perspectives of key stakeholders during the development process of confirmatory-phase adaptive clinical trials within an emergency clinical trials network and to build a model to guide future development of adaptive clinical trials.

Methods

We used an ethnographic, qualitative approach to evaluate key stakeholders' views about the adaptive clinical trial development process. Stakeholders participated in a series of multidisciplinary meetings during the development of five adaptive clinical trials and completed a Strengths-Weaknesses-Opportunities-Threats questionnair

SUBMITTER: Mawocha SC 

PROVIDER: S-EPMC5446276 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature